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Completed

NCT Number: NCT02195323

Autologous Bone Marrow Derived Mesenchymal Stromal Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)

This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs) therapy in chronic kidney disease (CKD).

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royan Institute

Tehran, Iran

About this study

We will assess the 18-month safety and potential efficacy of autologous MSCs as a therapy for CKD. A total of 10 patients with CKD IV injection of high doses 2×106/kg of autologous MSCs t, which will be derived from biopsies of their bone marrow. Assessments will be performed at 1, 3, 6, 12 and 18 months after cell injection. Changes in Glomerular Filtration Rate (GFR) were evaluated by scan isotope.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and Female
  • CKD symptoms
  • CKD confirmed with serum and urine analysis and GFR 25-60 mL/min/1.73 m2
  • Patient's age between 25 - 60 years
  • Ability to understand and willingness to sign consent from

Exclusion criteria

  • Pregnant or lactating
  • Basis disease such as diabetes, malignancy and autoimmune
  • Unable to follow post-operative exercise regimen or return for evaluations

Treatment and study plan

Intravenous injection

Biological

Intravenous injection of bone marrow derived MSC in patients with CKD.

Other names: Intravenous transplantation

Primary outcomes

  1. mass formation

    Time frame: 6months

    Evaluation the probability of mass formation due to MSC transplantation 6 months after cell injection.

  2. Creatinin

    Time frame: 1 month

    Evaluation the rise of creatinin 1 month after cell transplantation.

Secondary outcomes

  1. GFR

    Time frame: 6months

    Evaluation the increase of GFR 6 months after cell transplantation with scan isotope .

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

Administration of Autologous Bone Marrow Mesenchymal Stem Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 21, 2014
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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